BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    Wireless Digital Flat Panel Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    SENTINEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124

    FDA 510(k)
    FDA Class 2 ·Radiology

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Death ·CORDIS NEUROVASCULAR, INC.·Product code NJE·August 23, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024